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Completed

NCT Number: NCT01073670

Indomethacin and Cardiac Bypass Surgery

Following signed informed consent, patients scheduled for elective cardiac surgery were randomly assigned to one of 3 groups to be given acetaminophen, Indomethacin or a combination of both immediately following induction and then at 6, 12, 18 & 24 hours following surgery. Our primary outcome measure was the amount of blood drained from the mediastinal tubes and chest drains. Secondary outcome measures included conventional blood coagulation indices as well as other measures of clotting as indicated by thromboelastography (TEG). Other secondary outcome measures included consumption of morphine equivalents and pain scores.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • scheduled to undergo either elective coronary artery bypass or single valve replacement
  • normal platelet count
  • normal prothrombin time
  • normal partial thromboplastin time
  • normal serum creatinine

Exclusion criteria

  • sensitivity to study drugs
  • history of bleeding diathesis
  • renal dysfunction
  • active peptic ulcer

Treatment and study plan

Indomethacin

Drug

Indomethacin was given via suppository at time of induction for anesthesia (2 x 50 mg) followed by one 50 mg suppository at 6, 12, 18 and 24 hours following cardiac bypass surgery.

Other names: Indocin

Acetaminophen & Indomethacin

Drug

Subjects were given a loading dose of acetaminophen (1300 mg) and indomethacin (50 mg)by suppository at the time of induction for anesthesia and then given 650mg acetaminophen + 25 mg indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.

Other names: Tylenol, Indocin

Acetaminophen

Drug

Subjects were given a loading dose of 2600 mg of acetaminophen (via suppository) at time of induction for anesthesia then given 1300mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.

Other names: Tylenol

Primary outcomes

  1. amount of blood lost via chest drains during and following cardiac bypass surgery

    Time frame: during surgery and then until chest drains removed (< 24 hours)

Secondary outcomes

  1. blood clotting indices (i.e., conventional and using thromboelastography)

    Time frame: perioperative period until 24 hours post-operative

  2. Morphine equivalents required to provide effective analgesia

    Time frame: perioperative period until 24 hours post-operative

    The milligram quantities of morphine or the equivalents of morphine administered (in addition to the acetaminophen, indomethacin or combination therapy) were recorded and compared between groups. This provided an indication of how effective each of our interventions were at providing pain relief.

  3. pain scores

    Time frame: perioperative period until 24 hours post-operative

    Resting pain scores were recorded for all subjects at 6, 12 18 and 24 hours following surgery and compared between groups. These scores provided an indication as to the efficacy of each of our interventions at providing pain relief.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

Quantification of Postoperative Coagulation Following Administration of Indomethacin to Expedite Fast-tracking of Cardiac Surgical Patients

Important dates

Study start
2000
Primary completion
2002
Study completion
2002
First posted
Feb 23, 2010
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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